Ask the Scholar

{
    "localId": "16988008",
    "label": "Health (6)",
    "core": "doc",
    "dtoType": "document",
    "citationUrl": "https://catalog.archives.gov/id/16988008"
}

{
    "id": "16988008",
    "sourceUrl": "https://catalog.archives.gov/id/16988008",
    "contentType": "document",
    "title": "Health (6)",
    "citationUrl": "https://catalog.archives.gov/id/16988008",
    "collections": [
        "James M. Cannon Files (Ford Administration)",
        "James Cannon's Issues Files"
    ],
    "subjects": [
        "Drugs",
        "Federal aid",
        "Genetics",
        "Health",
        "Insurance",
        "Legislation",
        "Medicaid",
        "Medicare",
        "National health insurance",
        "Presidential campaign, 1976"
    ],
    "iiifBase": "https://s3.amazonaws.com/NARAprodstorage/lz/presidential-libraries/ford/grf-0039/635863/16988008.pdf",
    "thumbnailUrl": "https://s3.amazonaws.com/NARAprodstorage/lz/presidential-libraries/ford/grf-0039/635863/16988008.pdf",
    "largeImageUrl": "https://s3.amazonaws.com/NARAprodstorage/lz/presidential-libraries/ford/grf-0039/635863/16988008.pdf",
    "imageCount": 1,
    "hasImages": true,
    "source": "import",
    "hasTranscription": false
}

{
    "url": "https://catalog.archives.gov/id/16988008",
    "naId": 16988008,
    "coverageEndDate": {
        "logicalDate": "1976-11-30",
        "month": 11,
        "year": 1976
    },
    "coverageStartDate": {
        "logicalDate": "1975-05-01",
        "month": 5,
        "year": 1975
    },
    "levelOfDescription": "fileUnit",
    "recordType": "description",
    "ocrSource": "nara-archive"
}

{
    "seq": 1,
    "pageIndex": 0,
    "type": "document",
    "url": "https://s3.amazonaws.com/NARAprodstorage/lz/presidential-libraries/ford/grf-0039/635863/16988008.pdf",
    "mediaId": "11c795148255f3e7",
    "ocrText": "The original documents are located in Box 16, folder \"Health (6)\" of the James M. Cannon\nFiles at the Gerald R. Ford Presidential Library.\nCopyright Notice\nThe copyright law of the United States (Title 17, United States Code) governs the making of\nphotocopies or other reproductions of copyrighted material. Gerald Ford donated to the United\nStates of America his copyrights in all of his unpublished writings in National Archives collections.\nWorks prepared by U.S. Government employees as part of their official duties are in the public\ndomain. The copyrights to materials written by other individuals or organizations are presumed to\nremain with them. If you think any of the information displayed in the PDF is subject to a valid\ncopyright claim, please contact the Gerald R. Ford Presidential Library.\nSome items in this folder were not digitized because it contains copyrighted\nmaterials. Please contact the Gerald R. Ford Presidential Library for access to\nthese materials.\nDigitized from Box 16 of the James M. Cannon Files at the Gerald R. Ford Presidential Library\nJuly 14, 1976\nDear Tom:\nMany thanks for your letter of\nJuly 7 restating your telegram to the\nPresident on S. 3184. It's great to\nhear from you, and I'll make sure your\nviews on S. 3184 are carefully considered.\nWith deep appreciation to you for\nwriting directly to me, and warm regard,\nSincerely,\nNelson A. Rocktfeller\nMr. Thomas P. Pike\nChairman\nFORD LIBRARY i GERALD\nNational Council on\nAlcoholism\n707 Wilshire Boulevard\nSuite 3157\nLos Angeles, California 90017\nMAR/GRA/dlb\nbcc: Jim Cannon with copy of incoming\nare nr la bw e is\nTHOMAS P. PIKE\n707 WILSHIRE BOULEVARD\nSUITE 3157\nLOS ANGELES, CALIFORNIA 90017\nJuly 7, 1976\nThe Honorable Nelson A. Rockefeller\nVice President of the United States\nWashington, D.C. 20540\nDear Nelson:\nFollowing is the telegram I have just sent to the President on S. 3184:\n\"Strongly urge you sign into law S. 3184 passed unanimously by the\nSenate and with only three dissenting votes in the House. Having worked\non this vital comprehensive alcoholism legislation since 1969, I was\ninstrumental in prevailing on former President Nixon to sign it as P.L.\n91-616 on December 31, 1970, over the veto recommendation of OMB\nand HEW. Although HEW's NIAAA has made tremendous progress in\ncombatting alcoholism since then, several more years of Federal funding\nand leadership are desperately needed to consolidate gains and complete\nthe foundations. Katherine and I know this first hand through our contin-\nuous involvement as members of HEW's National Advisory Council on\nAlcoholism since 1970. Mr. President, Katherine and I earnestly be-\nspeak your signature on S. 3184 on behalf of ten million American\nalcoholics and the forty million members of their families. Warm\npersonal regards.\"\nI'm deeply convinced the country desperately needs a continuance of\nthis alcoholism legislation and a veto seems certain to be overridden\nby Congress.\nI hope that you will make the President aware of my views before he\nmakes his decision and that you will urge him to sign S. 3184.\nSincerely,\nThomas Jan\nGREATS FORD CIBRARY\nChairman\nNational Council on Alcoholism\nTPP:md\nDEPARTMENT OF HEALTH, EDUCATION AND WELFARE\nHealth\nOFFICE OF THE SECRETARY\nWASHINGTON DC 20201\nJUL 16 1976\nMEMORANDUM FOR THE HONORABLE JAMES M. CANNON\nI am writing in response to your memorandum of June 24 in\nwhich you request further information concerning my memorandum\nof June 18 to the President. As you know, the National\nInstitutes of Health (NIH) released guidelines on June 23\nfor recombinant deoxyribonucleic acid (DNA) research supported\nor conducted by NIH. The purpose of the committee I proposed\nto the President in my memorandum would be to review and\ncoordinate Federal agency policies and actions in this re-\nsearch area in light of the NIH guidelines.\nIn response to your questions concerning the proposed committee,\nit is my intent that this committee shall be composed solely\nof Federal officers and employees representing all departments\nand agencies which conduct, support, or have possible regulatory\nauthority over the conduct of recombinant DNA research. Such\na committee is specifically excluded from the provisions of the\nFederal Advisory Committee Act. The relevant section of that\nAct is as follows:\nSec. 3. For the purpose of this Act-\n(2) The term \"advisory committee\" means any\ncommittee, board, commission, council,\nconference, panel, task force, or other similar\ngroup, or any subcommittee or other subgroup\nthereof (hereafter in this paragraph referred to\nas \"committee\"), which is--\n(A) established by statute or reorganization\nplan, or\n(B) established or utilized by the President,\nor\n(C) established or utilized by one or more\nagencies,\nin the interest of obtaining advice or recommendations\nfor the President or one or more agencies or officers\nof the Federal Government, except that such term\nexcludes (i) the Advisory Commission on Intergovernmental\nRelations, (ii) the Commission on Government Procurement,\nand (iii) any committee which is composed wholly of\nfull-time officers or employees of the Federal Government.\n(Emphasis added.)\nThe Honorable James M. Cannon\n2\nThus, the proposed committee, inasmuch as it would be composed\nsolely of Federal officers and employees, would not need to be\nchartered under this Act.\nYou also ask how this proposed committee relates to S. 2515,\nwhich would modify the present National Commission for the\nProtection of Human Subjects of Biomedical and Behavioral\nResearch. In the bill, which recently passed the Senate, there\nis a provision concerning recombinant DNA research. The\nCommission is authorized to conduct a study of the ethical,\nsocial, legal, and safety implications of recombinant DNA\nresearch and devise guidelines, if appropriate. I am enclosing\na copy of a letter that I am planning to send to Congressman\nHarley O. Staggers, Chairman of the Committee on Interstate\nand Foreign Commerce of the House of Representatives, commenting\non the bill. In the letter is outlined the Department's\nstated opposition to S. 2515, including comments that the study\nof recombinant DNA research proposed for the Commission would\nduplicate the efforts of NIH.\nIn my view, it is most important that we be able to proceed\nas expeditiously as possible to organize an intergovernmental\ncommittee to review the experience of NIH and, where appropriate,\nmake recommendations for the other Federal departments and\nagencies and possibly for the private sector. Legislative\nprospects for S. 2515 are uncertain at best. Further, even if\nthe Congress were to pass legislation to create such a\nPresidential Commission, over the Administration's objections,\nand it were to become law, there would be certain administrative\ndelays in reorganizing and reconstituting such an entity. And\neven if the Commission were to undertake such a study, it would\nstill not meet the stated needs of the committee that I am\nproposing. The committee would have a far broader mandate\nand a broader representation of interested parties.\nI have received a considerable amount of correspondence on\nthis research activity in the past several months. In these\nletters there has been special emphasis by public commentators\non the need for uniformity in the conduct of recombinant DNA\nresearch. The committee I propose would be most responsive\nto this public concern. I strongly urge you to recommend to\nthe President that I be allowed to proceed in this matter\nwithout undue delay.\n/s/Marjorie Lynch\nActing Secretary\nEnclosure\nHEALTH\nDUT\nNOTAL\nDRAFT\nSECURITY\nDEPARTMENT OF HEALTH, EDUCATION. AND WELFARE\nUSA\nThe Honorable Harley 0. Staggers\nChairman, Committee on Interstate\nand Foreign Commerce\nHouse of Representatives\nWashington, D.C. 20515\nDear Mr. Chairman:\nThis is in response to your request for a report on S. 2515, a bill \"To\namend the Public Health Service Act to establish the President's Commis-\nsion for the protection of human subjects involved in biomedical and\nbehavioral research, and for other purposes.\"\nIn summary, we oppose S. 2515 as passed by the Senate because the existing\nstatutorily established National Commission for the Protection of Human\nSubjects of Biomedical and Behavioral Research has yet to complete its\nrecommendations. These are to include the development of an effective\nFederal administrative mechanism for applying its ethical guidelines to\nresearch programs conducted or supported by Government departments or\nagencies, including its definition of the function and authority of the\nproposed National Advisory Council for the Protection of Subjects of\nBiomedical and Behavioral Research.\nWe feel that the recommendations of the present National Commission will\nmake an invaluable contribution toward the development of a consistent\nGovernment-wide plan for the protection of human subjects of biomedical\nand behavioral research. Assuming that such an administrative framework\nwill be based on the guidelines currently being recommended to the\nDepartment of Health, Education, and Welfare, we favor an Executive\nOrder to extend Departmental regulations on the protection of human\nsubjects uniformly to all other Federal agencies and departments rather\nthan legislative creation of a new Presidential Commission.\nS. 2515, as amended, would in effect replace the Commission created in\nTitle II of the National Research Act. The new President's Commission\nwould be permanent and would contain eleven members plus ex officio\nadvisors from the Department of Health, Education, and Welfare, the\nDepartment of Defense, the Central Intelligence Agency, the Science\nAdvisor to the President, and the Veterans Administration. The President's\nCommission would assume the functions, powers, and duties of the current\nNational Commission and expand its jurisdiction to encompass all Federal\ndepartments and agencies conducting research involving human subjects.\nPage 2 - The Honorable Harley 0. Staggers\nIn addition to the duties prescribed for the National Commission, the\nPresident's Commission would be responsible for continually reviewing\nand analyzing the ethical, social, and legal implications of all research\non human subjects supported by the Federal Government, and for making\nappropriate recommendations concerning the protection of human subjects\nto the supporting agency. These recommendations would be published in\nthe Federal Register and, if the responsible agency chooses not to\nfollow them, the negative determination and the reasons for it would be\npublished in the Federal Register.\nThe President's Commission would also be required to study the ethical,\nsocial, legal, and safety implications of recombinant DNA research on\nresearch personnel, human subjects of the research, and the public at\nlarge.\nWe strongly endorse efforts to protect human subjects of biomedical and\nbehavioral research. However, in addition to establishing a mechanism\nwhich we do not believe is necessary, the structure of the proposed\ncommission contains some administrative shortcomings.\nFirst, the President's Commission would be independently advisory to the\nseveral Federal agencies and departments, rather than to the Government\nas a whole. Thus, there would be an opportunity not only for uncoordi-\nnated advice but for disparate, inconsistent, and possibly conflicting\nresponses on the part of agencies conducting similar research. Second,\nthe proposed ex officio membership would not represent the extent of\nbiomedical research carried out by other Federal agencies, such as the\nEnergy Research and Development Administration, National Aeronautics and\nSpace Administration, Department of Transportation, or Department of\nAgriculture. Third, there are no positions or funds authorized to\nsupport the activities of the proposed Commission.\nOne of the recommendations already made by the National Commission for\nthe Protection of Human Subjects is that there be established a national\nreview body to consider ethical problems raised by research proposals\nwhenever the application of recommended standards proves difficult. The\nDepartment of Health, Education, and Welfare is establishing an Ethical\nAdvisory Board to provide advice to the Public Health Service and other\ncomponents of the Department on ethical issues and on classes of applica-\ntions or proposals which (1) must be submitted to the Board or (2) need\nnot be submitted to the Board (45 CFR 46.204). Creation of the Ethical\nAdvisory Board will create a more flexible instrument for dealing with\nethical dilemmas concerning human research subjects than the proposed\nPresidential Commission.\nPage 3 - The Honorable Harley 0. Staggers\nFinally, we are very aware of the controversy over recombinant DNA\nresearch and have recently released guidelines according to which support\nmay be given for research conducted by grantees, contractors, and intra-\nmural scientists. The National Institutes of Health, Public Health\nService, has gone to great lengths to involve the Congress, the public,\nand the press in the decisionmaking process which has addressed the\nsocial, legal, ethical, and safety implications of such research. It\nhas sought and received advice from many sectors--scientists, ethicists,\nlawyers, and consumer representatives--and has taken all comments into\naccount in preparing the guidelines for this activity. While we do not\noppose having the guidelines reviewed by another advisory body, we feel\nthis is already being done under present authority.\nWe therefore recommend that S. 2515 not be favorably considered at this\ntime, and that any legislative initiatives concerning Federal regulation\nof research involving human subjects be delayed until the existing\nNational Commission for the Protection of Human Subjects has made its\nfinal report and recommendations to the President and the Congress as\nrequired by the National Research Act.\nWe are advised by the Office of Management and Budget that there is no\nobjection to the presentation of this report from the standpoint of the\nAdministration's program.\nSincerely,\nSecretary\nOFFICE OF THE COVERNOR\nHealth\nSTATE OF OHIO\nOFFICE OF THE GOVERNOR\nTHIS\nOF\nOHIO\nCOLUMBUS 43215\nJAMES A. RHODES\nGOVERNOR\nJuly 20, 1976\nThe Honorable David F. Mathews\nSecretary of Health, Education, and Welfare\nWashington, D. C.\n20201\nGERALD FORD LIBRARY\nDear Secretary Mathews:\nOhio faces a severe financial crisis in its Medicaid program.\nThe severity of this crisis is apparent when you compare the\nappropriation of $471 million (state funds plus projected federal\nearnings) which is available for fiscal year 1977 with the pro-\njected expenditures of $597 million required to support the\nFY 77 Medicaid program in its present form.\nThis situation is further compounded by the fact that Ohio is\nunder court order not to reduce the scope of the current program\nuntil pre-reduction hearings are provided to eligible recipients.\nThe projected deficit of $126 million in the Medicaid program has\nbeen the subject of much publicity, legislative committees have\nexamined the program and many medical provider associations have\nprovided suggestions and recommendations. Since the projected\ndeficit includes both state funds and federal earnings, Ohio needs\nyour recommendations as to how this situation might best be re-\nsolved. I understand that the federal funds required to support\nthe program are indeed available to Ohio but only if the state\ncertifies that it can provide the necessary state matching funds.\nYour verification of this requirement would be most helpful,\nWithout an increase in state matching funds, Ohio cannot continue\nthe existing Medicaid program, The problem becomes critical on\nNovember 15, 1976, when the federal estimates for the January-\nMarch 1977 quarter are due, Without an increase in state funds\nprior to this date, Ohio will not be able to certify the avail-\nability of sufficient state funds to maintain the Medicaid program\nfor FY 77. It is anticipated that the current appropriation will\nbe exhausted in February 1977 and Ohio will be forced to discontinue\nthe Medicaid program for lack of funds.\nI plan to propose a reallocation of state funds that will insure\nthe continuation of Ohio's Medicaid program through fiscal year\n1977. Immediate action is necessary if Ohio is to avoid a repeat\nof the FY 76 crisis when Medicaid funds were exhausted on May 11,\n1976. I need your support to reinforce the necessity for a speedy\nbut effective solution to the Medicaid crisis, Attached is a\nsuggested letter for your signature which would accomplish that\npurpose.\nSecretary David F. Mathews\nJuly 20, 1976\nPage 2\nAlso attached is a letter from Clyde V. Downing of the Chicago\nRegional Office showing that this estimate of the total funds to\ncontinue Ohio's Medicaid program for FY 77 is $540 million. To\nthis estimate must be added the backlog of unpaid FY 76 bills\namounting to over $68 million, This letter will provide assurance\nthat the fund requirements for Ohio's Medicaid program have not\nbeen overstated and that additional funds are truly required if\nthe Medicaid program is to continue.\nThere is also attached a copy of a memo from my Office of Budget\nand Management attesting to the appropriation of both state funds\nand federal earnings that is currently available to support Ohio's\nFY 77 Medicaid program.\nLam Governor Sincerely AMES A. RHODES\nJAR:em\nAttachments\nCERALO FORD\nDraft of a letter from Secretary Mathews to Governor Rhodes:\nDear Governor Rhodes:\nResponding to your recent inquiry concerning the requirement\nfor state matching funds in the Medicaid program, I must advise\nyou that the availability of federal funds is dependent upon\nthe assurance from the state that state matching funds are\navailable to support the total program expenditures. Without\nsuch assurance there is no legal basis for the provision of\nfederal funds.\nI should also point out that Ohio's state plan for the Medicaid\nprogram has been accepted and approved as a plan for a con-\ntinuing program that would operate only for a limited time\nduring a fiscal period dependent upon the availability of\nfunds. The state-federal partnership in the funding of the\nMedicaid program is based upon the premise that each of the\npartners will commit the necessary resources to insure con-\ntinuing operation of the program, Failure of either party to\nprovide such assurance can only serve to negate the concept\nupon which the federal-state partnership is based.\nI would encourage you to do everything within your power to\ninsure that Ohio provides the necessary state matching funds\nto support the continuation of Ohio's Medicaid program which\nis so vital to health care needs of Ohio's citizens.\nSincerely,\nDAVID F. MATHEWS\nSecretary\nETORO\nLIBRARY\nState of Ohio Office of Budget and Management\n30 East Broad Street\nColumbus, Ohio 43215\n(614) 466-3085\nJuly 20, 1976\nMEMORANDUM TO:\nGovernor James A. Rhodes\nFROM:\nWilliam W. Wilkins, Director\nWilliam\nW.Wilkins\nOffice of Budget and Management\nSUBJECT:\nFY 77 Medicaid Appropriation\nThis will certify the amounts appropriated to support Ohio's Medicaid\nprogram. These appropriations include projected Federal matching funds.\nFrom Amended Substitute HB 155 - $ 410,631,513\nFrom Amended Substitute HB 1508-\n60,000,000\n*\nTotal Appropriation\n$ 470,631,513\n* Subject to release by the State Controlling Board\nWWW:cb\nHEALTH\nDEPARTMENT\nIDUC\nARTMENT\nDEPARTMENT OF HEALTH. EDUCATION. AND WELFARE\nREGION V\n... 50018 BACKER with\nCHICAGO. ILLINOIS 6060£\nSOCIAL a REHABILITATION\nSERVICE\nJune 30, 1976\nEXECUTIVE\n2- 700 92.\nMr. Kwegyir Aggrey, Director\nRECEIVED\nOhio Department of Public Welfare\nState Office Tower, 32nd Floor\n30 E. Broad Street\nColumbus, Ohio 43215\nDear Mr. Aggrey:\nThe Regional Office estimate of total expenditures for the Medicaid\nProgram in Ohio, as requested in your letter of June 17, is $539,872,000\nfor the period July 1, 1976 through June 30, 1977, compared to your\nMay 3 estimate of $536,662,000 for the same period.\nThis estimate was derived for Federal Budget purposes from historic\nmedical expenditure trends as provided by the State, through its normal\nstatistical and monetary reporting system. It is based on the program\ncontinuing in its present form and providing the identical service\nclassifications.\nSincerely,\nalyli\nClyde V. Downing\nRegional Commissioner, ? SRS\nRegion V\nHEALTH.\nto\nPRICATION\nINTERNATIONAL SECURITY AND\nTHE UNDER SECRETARY OF HEALTH, EDUCATION, AND WELFARE\nWASHINGTON, D.C. 20201\nU.S.K.\nJuly 21, 1976\nMEMORANDUM TO THE HONORABLE JAMES CANNON\nEnclosed are the Department's Reports\non Major Initiatives which you requested.\nhearing Marjorie Lynch hyrch\nUnder Secretary\nEnclosures\nCC: Mr. David Lissy\nFORD LIBRARY\nDr. James Cavanaugh\nMiss Sarah Massengale\nOVERVIEW OF TITLE XX\nTitle XX of the Social Security Act was a far-\nreaching reform of public social services. The title\nprovided for goal oriented services, allowed the States\nto determine which services they would provide, and\nrequired that States develop an open planning process\nwith citizen participation, The clear intent of the\nlaw was to allow States greater flexibility in the\nplanning and delivery of social services.\nAfter the first year of Title XX operation, HEW\nin connection with States, counties, State legislatures\nand cities undertook a comprehensive review of Title XX\nregulations. The purpose of this review was to remove\nthose aspects of the regulations which reduced State\nflexibility or caused serious administrative problems\nThese regulations are being revised to the extent possible\nwithin the statute to remove these barriers. The President\nintroduced the Community Services Block Grant which would\nfurther remove the statutory barriers to State flexibility\nfor public social service programs. A more detailed des-\ncription of Title XX is attached.\nMEMORANDUM\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nOFFICE OF THE SECRETARY\nTO\n:\nMichael Licata\nDATE: July 20, 1976\nES\nFROM : ORR Glenn Kamber GK.\nSUBJECT: Major Initiatives Report for the Domestic Council\nThe Secretary has made regulatory reform one of his highest\npriorities in the Department. In order to coordinate the\nefforts of the Department in regulatory reform, the Secretary\nestablished the Office of Regulatory Review on February 3,\n1976. The Secretary announced a two-fold objective for\nregulatory reform in the Department:\n1. Improve the process by which new regulations,\neither proposed or final, are developed, cleared\nand reviewed; and,\n2. Review existing regulations to recommend which\nones can and should be modified, simplified, or\neliminated.\nTo accomplish these two major objectives and to incorporate\nthe Secretary's initiative to open the processes of HEW to\nmore public involvement the following six major activities\nhave been initiated:\nMeetings about the regulations development process\nto solicit ideas for changes needed in that process\nhave been held with over 150 HEW-related interest groups\nas well as with all key Department personnel.\nA high-level Departmental Task Force composed of\nrepresentatives from each agency within the Department\nwas formed to review the regulations development process\nand presented recommendations for change to the Secre-\ntary on April 8, 1976. Included in these recommendations\nare methods to open the system to more meaningful public\ninvolvement, to provide for earlier decision-making\nby the Secretary and Under Secretary, to assure more\ntimely development of regulations and to formalize the\n\"periodic review\" of regulations to evaluate their im-\npact and effectiveness.\nA Task Force composed of personnel from the Federal\nRegister, SRS, SSA and H, was established in June to\nrecodify the Medicaid regulations (which will include\na review of all regulations, guidelines, memoranda and\npolicy letters).\nA Task Force composed of personnel from the Office of\nEducation will be formed in August to develop regulations\nfor the Higher Education and Vocational Education Acts.\nThe two-fold objective of this OE Task Force is to pro-\nvide a model for implementing regulations as mandated\nby the new legislation and to recodify the existing\npertinent regulations to produce a unified, consistent\nand clearly written set of final regulations.\nTraining sessions in the regulations process and clear\nwriting of regulations are being conducted within each\nagency. The goal of these pilot training sessions is\nto develop a training program which can be applied\nthroughout the Department so that regulations will be\nwritten in clear, simple and easily understood manner.\nCurrent regulations are often written in legal and program\njargon which often cannot be understood by the ordinary\ncitizen. These courses are being developed with the\ncooperation of Federal Register personnel.\nA study is underway to investigate how computer\ntechnology can be applied to the regulations development\nprocess. Included in the study will be the possible uses\nof computer systems for internal monitoring for the\nentire development process and for cataloging existing\nregulations.\nExcluding the Food and Drug regulations, HEW regulations\ncurrently cover 3,167 pages of the Code of Federal Regulations.\nApproximately 500 items that must be signed by the Secretary\nwill be sent to the Federal Register this year.\nWe believe that these activities to reform the regulation\nprocess and review existing regulations are positive and\nconstructive responses by the Department to the public as it\nis affected in the vital areas of service delivery in the\nnumerous areas that are touched upon by policies and programs\nemanating from the Department of Health, Education and Welfare.\nMEMORANDUM\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nSOCIAL AND REHABILITATION SERVICE\nOffice of the Administrator\nTO\n:\nDATE:\nMichael J. Licata\nJuly 21, 1976\nExecutive Secretary\nto the Department\nFROM\nAdministrator\n:\nSocial & Rehabilitation Service\nSUBJECT:\nMajor Initiatives Report\nAttached is material pertinent to the Title XX proposals to be used\nas part of a summary of major initiatives undertaken or completed\nduring the last two years.\nDallot Robert Fulton\nAttachment\n1\nTitle XX of the Social Security Act\n1. Then and now facts\nThe title XX social services program is the result of a collaborative\neffort on the part of the Congress, the Department, the State adminis-\ntrators, the National Governors Conference, and numerous organizations\nconcerned with services for children, the aged, the handicapped and\nother groups. By creating title XX (Public Law 93-647) this coalition\nresolved an impasse of some 20 months when no one could agree on new\nregulations for titles IV-A and VI and what direction public social\nservices should take.\nEffective October 1, 1975 in the 50 States and the District of Columbia,\nthe title XX program began, providing services for needy families and\nchildren (formerly served under title IV-A of the Social Security Act),\nneedy aged, blind and handicapped (previously served under title VI of\nthe Act), and, at State option, intact families, childless couples, and\nsingle (not old, not handicapped) persons with incomes net exceeding\n115% of the State or national median income as adjusted for family size.\nUnder title IV-A, fees could be charged for child care. Under title XX,\nfees were mandatory for persons with a gross monthly family income above\n80% of the median income and up to 115% of it. But while the universe of\npopulation under title XX seemed broader than for the predecessor titles,\nthe focus was still on the poor as shown by the legislation which required\nthat an amount equal to 50% of the Federal contribution be used for\nservice expenditures for recipients of AFDC (title IV-A), SSI (the Supplemental\nSecurity Income program under title XVI), and Medicaid.\nGone were the \"former\" and \"potential\" recipients of title IV-A and VI\nand the determination of eligibility on a group basis.\nTitle XX introduced a new concept of \"universal\" services - that is\ntwo services which a State might provide to anyone without regard to\ntheir incomes: information and referral services and services to prevent\nor remedy abuse, neglect or exploitation of children or adults.\nThe requirement for providing services on a Statewide basis remained; but\nunder title XX, a State could divide itself into geographic areas (encompassing\nthe whole State) and vary services by geographic areas according to the needs\nof the eligibile persons there and availability of resources.\nThe same ceiling remained on social services, $2.5 billion, and the\nallocation formula was still on the basis of population. However, if States\ndid not certify complete usage of their allocations under title XX, $15\nmillion of the remainder could be allocated to Puerto Rico and $500,000\neach to the Virgin Islands and Guam for services under title I, IV-A, X,\nXIV or XVI (AABD). There was no change in the Federal match: 75% for\nservices and administration; 90% for family planning services. States\ncould still receive donations from public or private agencies under the\nsame circumstances to use as the State match, and services could be provided\nby title XX staff, by referral, or by purchase. As under the previous\ntitles, States with title XX programs may be found out of compliants and\nbe subject to withholding of Federal funds. However, under title XX the\nThen and now - continued\n2\nHEW Secretary has the option of withholding 3% of funds otherwise\npayable to the State for each requirement out of compliance, as well\nas withholding all funds.\nState\nThe same/organizational unit which operated title IV-A had to operate\nthe program under title IV-B (child welfare services). Likewise, the\ntifle XX State agency must operate the IV-B program (except in Illinois\nwhere there is a separate child welfare services unit).\nThere were numerous mandatory services under the \"old\" titles. This\nconcept is vestigial under title XX: three SSI services in each\ngeographic area, family planning services for all AFDC recipients who\nrequest them, and at least one service in each geographic area to\ncarry out each of title XX's national goals. These goals are: self-\nsupport, self-sufficiency; services to prevent or remedy abuse, neglect\nor exploitation of children or adults; reuniting families; deinstitu-\ntionalization when appropriate; institutionalization or services\nwithin some institutions when necessary. Title XX is completely goal-\noriented both in assessing the needs of an applicant and reporting on\nservices given.\nTitle XX departs radically from the two former programs in that it\ndecentralizes planning out of Washington and places it in the States\nwhere the leadership and people are closer together and can presumably\nbetter articulate needs and allocate resources. The vehicle for this\nthrust is the open planning process conducted on a yearly basis. The\nstatute spells out how the State must develop, publish and make generally\navailable a proposed services plan 90 days before the program year\nbegins. Minimally, the State must publish a display advertisement in\nnewspapers covering each geographic area detailed in the plan and provide\ncopies of the plan or a summary of it. A comment period of 45 days\nfollows publication of the ad. States also use public hearings, radio\nand TV to solicit public input. What the public is commenting on is\nthe contents of the plan: who is eligible for what services in what\ngeographic area; criteria for eligibility; description of each service\noffered; fee schedule if any; the Federal allotment and how much the\nState will spend of it, the State contribution (also local and donated);\nthe needs assessment; how evaluation and reporting will be conducted;\nprojected estimates of numbers of persons to be served with what\nservices where; how it will coordinate with other human services programs;\nhow the title XX agency is organized. (Priorntothe start of the program,\nSRS issued a Citizens Handbook to explain the program to the public.\nMany thousands were put into circulation.) When the 45 days are up and\ncomments are analyzed, a final services plan is published (minimally in\na display ad in the same newspapers as before) explaining the differences,\nif any, between the proposed and final plans.\nfinal\nThere is a procedure for amending the/services plan which is like that\nfor a proposed services plan but has a 30-day comment period.\nThis kind of open planning permits great flexibility, affords an opportunity\nfor initiative at the grassroots, and is expected to result in programs\nmore nearly meeting the needs of the State's residents.\nThen and now - continued\n3\nThe title XX agency must also prepare a second plan covering adminis-\ntrative aspects of the program - such as fair hearings, use of\nMerit System for agency personnel, safeguarding information, standards,\netc. This plan must be submitted for approval to SRS. The services\nplans are reviewed by SRS to see that they montain all the items\nrequired by the legislation and regulation, but SRS does not have\napproval authority.\nThe Federal role under title XX is to provide technical assistance,\nmonitor and evaluate the program and report to Congresson it.\n2. Highlights and key numbers\n- Almost $3 billion was expended for title XX in FY 1976, of\nwhich $2.2 billion, or 75%, was the Federal share.\n- Expenditures increased 40% from $1.6 billion in FY 1974. to\n$2.2 billion in FY 1976. Expenditures are projected at\n$2.35 billion in FY 1977.\n- In FY 1974, expenditures represented 63% of the States'\nentitlements, increasing to 88% in FY 1976, and estimated at\n94% in FY 1977.\n- In FY 1974 only 7 States used their full entitlements com-\npared to 21 in FY 1976 and estimated at 34 States in FY 1977.\n- Child day care, the largest single service provided accounted\nfor $546 million, or 25% of the Federal expenditures in\nFY 1976.\n- Expenditures for training and retraining of persons engaged\nin the delivery of title XX services increased from $43\nmillion in FY 1974 to $54 million in FY 1976.\n4\n3. Concerns or problems encountered in the title XX program in the\nlast two years (major areas):\na. Making the transition from the two preceding services programs\nSetting up and implementing a new planning process on a yearly\ncycle, educating the public to the new concept and developing\nmethods to obtain public input into the planning;\nConverting contracts under the \"old\" titles to conform to the\nrequirements for purchase of services under title XX;\nSetting up information systems for reporting title XX services\nand expenditures.\nb. Determining eligibility\nMethods of performing initial detammination of eligibility and\nredetenmination, including time periods and availability of\nFFP; pressure for determining eligibility on a group basis (as\nhad been possible under titles IV-A and VI), especially for\nsenior citizens (legislation constantly being introduced); pres-\nsure for considering as one-person families various groups\nsuch as youth for certain services (family planning, drug abuse),\nhandicapped youth and adults living with family members; children\nin foster care. The regulations were amended three times to\ndeal with matters of eligibility.\nC. Child Care\nAlthough the Federal Interagency Day Care Requiremen (SI(FIDCR)\nhad been required under title IV-A, the title XX legislation\nspecified their use and the regulations made it a matter of FFP\nif States did not adhere to these requirements and additional\nones on staffing for children under six years of age in day\ncare outside their homes, required by the regulations. Some\nStates could not meet these standards and legislation was always\nbeing introducedito afford some relief to theStates. One sus-\npension of the new staffing standards was in effect to the end\nof January 1976 and another bill has passed the House to continue\nthis suspension and otherwise assist the States in child care\nmatters.\nd. Confidentiality\nWith heavy emphasis on confidentiality of records throughout\nthe nation and a growing fear of the citizenry of centralized\ngovernment \"data banks,\" much concern has been expressed by\nservices consumers about providing information necessary for\nacountability of expenditures and demographic knowledge about\nthe program. Service providers are also reluctant to supply\nsuch information about the title XX eligibiles they serve with\ntitle XX funding. Several suits were brought against the Depart-\nment and others threatened.\ne. Rigidity of the statute\nThe statute is very specific about details of planning and preparing\n5\nConcerns (continued)\nand publicizing the proposed and final services plans and\nspecifying time frames in which certain tasks must be\naccomplished. This lack of flexibility often has jeopardized\nFFP to the States when a specific procedure or required content\nof the plan has been inadvertently overlooked. Since the\nregulations must implement the law, they are often criticized for\nbeing \"too tight.\"\nIn an effort to accommoda te to the realities S of operation of the\nprogram, the Department has amended the regulations four times already\nand is now embarked on a fifth, major, comprehensive amending - all\nwithin the first year of the program. The purpose is to simplify the\nadministrative requirements as much as possible and remove to the\ngreatest extent the potential for having to penalize the States financially.\n4. Key quotes\na. Senator Walter F. Mondale (D., Minn.) who introduced the \"Social\nServices Amendments of 1974 on behalf of himself and Senators\nJavitz, Packwood and Bentzen, in the Senate, September 20, 1974:\n\"This program provides special help for the elderly and disabled,\nalcoholism and drug rehabilitation, and a host of other services\ndirected toward preventing welfare dependency, avoiding unnecessary\ninstitutionalization, and strengthening family life.\"\nb. Former Secretary of HEW, Caspar W. Weinberger, announcing his\nsupport for the bill, October 3, 1974:\n\"The proposed amendments make theState social services program\nanswerable primarily to the State's citizens, within broad\nFederal guidelines. I am convinced that this new approach can\nFORD\nfree us all to concentrate on getting services to people.\nc. President Ford on signing the bill, January 4, 1975:\nLIBRARY\n\"The provisions concerning the Federal-State partnership program\nfor social services successfully concludes many long months cf\nnegotiations among the Congress; the Department of Health, Education,\nand Welfare; governors; State administrators; and spokesmen for\nproducers and consumers. Ending a long impasse, the efforts of\nall exemplify my call for communication, cooperation, conciliation\nand compromise when I assumed the office of President\n\"\n\"I am particularly pleased that this legislation follows a\ndesireable trend in Federal-State relations. It will improve the\nresults of programs previously hampered by unrealistic assumptions\nof Federal review and control. These decisions related to local\nconditions and needs will be made at the State level, while Federal\nresponsibilities are clearly delineated. Indeed, the interests of\nnot only the Federal andState governments, but also producers and\nconsumers are recognized and protected. I also believe that this\nnew legislation significantly improves program accountability and\nQuotes (continued)\n6\nfocuses on those most in need of services.\n\"In summary, I regard the social services provisions as a\nmajor piece of domestic legislation and a significant step\nforward in Federal-State relations.\"\n5. Referernce to or contact with outside groups\nThe collaborative effort which resulted in development and\nenactment of theSocial Services Amendments of 1974 (Title XX)\nhas continued. There is constant consultation between the\nDepartment (principally through the Social and Rehabilitation\nService and its Public Services Administration) on policy\ndevelopment with State administrators, relevant members of\nCongress, national voluntary advocacy groups, the National\nGovernors Council, NERO, NACO, other parts of HEW and other\nFederal agencies. The Department meets with these groups,\ncommunicates by telephone and mail and solicits input into\nregulations in the developmental stage and when regulations\nare issued in proposed form. One of the major coalitions\nwhich serves in an advisory capacity is the Human Resources\nForum.\nMEMORANDUM\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nSOCIAL SECURITY ADMINISTRATION\nTO\n: Executive Secretary to the Department\nDATE:\nJuly 20, 1976\nREFER TO: IPE-4\nFROM : Harris Factor, Director\nExecutive Secretariat, SSA\nSUBJECT: Major Initiatives in Medicare Legislation (Your memorandum of 7/20)--ACTION\nAttached for your use in responding to the request from the Domestic\nCouncil for a summary of major initiatives in Medicare legislation\nis a brief discussion paper on the Administration's proposed Medicare\nImprovements of 1976.\noff\nHarris Factor\nAttachment\nReport from the Commissioner of Social Security Concerning\nMajor Initiatives in Medicare Legislation\nOver the course of the last 2 years the Social Security Administration's\nmajor legislative initiatives concerning the Medicare program have\nbeen proposals which would: provide protection against catastrophic\nillness; restructure beneficiary cost sharing; and introduce other\nfeatures into the Medicare program to help reduce the rate of\ninflation in medical care costs generally and the corresponding growth\nin Medicare program expenditures.\nThe Administration's most recent legislative proposal was submitted\nto the Congress on February 11, 1976, as the \"Medicare Improvements\nof 1976.' The proposal would modify Medicare's cost-sharing structure\nto provide: (1) unlimited days of covered hospital (except psychiatric\nhospital) and skilled nursing facility care; (2) a coinsurance equal\nto 10 percent of all charges above the inpatient hospital deductible\namount (currently $104) for all services covered under Medicare's hospital\ninsurance (part A) program; (3) an increase in the annual deductible\namount under Medicare's supplementary medical insurance (part B) program\nfrom $60 to $77 in 1977; (4) a coinsurance equal to 10 percent of charges\nabove the deductible amount for all hospital-based physicians and part B\nhome health services; and (5) under part A, a maximum cost-sharing\nliability limit of $500 per year in 1976 and 1977, and under part B,\na maximum cost-sharing liability limit of $250 in 1977. The part B\ndeductible amount and the cost-sharing liability limits under part A and\npart B would be increased after 1977 in proportion to increases in\nsocial security cash benefits.\nThe Medicare Improvements of 1976 also contains cost-control provisions\nunder which Medicare would not recognize for reimbursement purposes\nincreases in hospital, skilled nursing facility, or other provider costs\nof more than 7 percent, or increases in charges for physician's and\nother part B covered services of more than 4 percent.\nIn his message transmitting to the Congress several Administration\nproposals for improvements in programs serving the elderly, the\nPresident outlined the purposes of the Medicare proposal as follows:\n\"There are weaknesses in the Medicare program which must be\ncorrected. Three particular aspects of the current program\nconcern me: 1) its failure to provide our elderly with\nprotection against catastrophic illness costs, 2) the serious\neffects that health care cost inflation is having on the Medicare\nprogram, and 3) lack of incentives to encourage efficient and\n1 of 3\neconomical use of hospital and medical services. My proposal\naddresses each of these problems.\n\"In my State of the Union Message I proposed protection against\ncatastrophic health expenditures for Medicare beneficiaries. This\nwill be accomplished in two ways. First, I propose extending\nMedicare benefits by providing coverage for unlimited days of\nhospital and skilled nursing facility care for beneficiaries.\nSecond, I propose to limit the out-of-pocket expenses of beneficiaries,\nfor covered services, to $500 per year for hospital and skilled\nnursing services and $250 per year for physician and other non-\ninstitutional medical services.\n\"This will mean that each year over a billion dollars of benefit\npayments will be targeted for handling the financial burden of\nprolonged illness. Millions of older persons live in fear of\nbeing stricken by an illness that will call for expensive hospital\nand medical care over a long period of time. Most often they\ndo not have the resources to pay the bills. The members of their\nfamilies share their fears because they also do not have the\nresources to pay such large bills. We have been talking about\nthis problem for many years. We have it within our power to\nact now so that today's older persons will not be forced to\nlive under this kind of a shadow. I urge the Congress to act\npromptly.\n\"Added steps are needed to slow down the inflation of health costs\nand to help in the financing of this catastrophic protection.\nTherefore, I am recommending that the Congress limit increases in\nmedicare payment rates in 1977 and 1978 to 7% a day for hospitals\nand 4% for physician services.\n\"Additional cost-sharing provisions are also needed to encourage\neconomical use of the hospital and medical services included under\nMedicare. Therefore, I am recommending that patients pay 10% of\nhospital and nursing home charges after the first day and that the\nexisting deductible for medical services be increased from $60 to\n$77 annually.\n\"The savings from placing a limit on increases in medicare payment\nrates and some of the revenue from increased cost sharing will be\nused to finance the catastrophic illness program.\n\"I feel that, on balance, these proposals will provide our elder\ncitizens with protection against catastrophic illness costs,\npromote efficient utilization of services, and moderate the increase\nin health care costs.\"\n2 of 3\nIt is estimated that the cost-sharing modifications in the Medicare\nprogram would reduce the costs of the program by $327 million in\nfiscal year 1977. The cost-control provisions are estimated to reduce\nMedicare outlays by an additional $1.2 billion. Together, these\nprovisions would reduce by one-third the projected 23-percent increase\nin Medicare program outlays in fiscal year 1977 under the provisions of\npresent law.\nA number of congressional committees have held hearings on the proposed\nMedicare Improvements of 1976. However, no committee has acted on this\nlegislation or reported it for consideration by the Senate or the\nHouse of Representatives. The Administration is currently reconsidering\nthis legislation with a view toward submitting its recommendations to\nthe 95th Congress.\n3 of 3\nSTATE\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nUAA\nWASHINGTON, D.C. 20201\nOFFICE OF THE SECRETARY\nJuly 20, 1976\nNOTE TO MICHAEL LICATA\nSubject: Major Initiatives Report\nIn response to your memorandum, attached is the major\niniative report on the Health Block Grants.\nbra Goldation\nIra Goldstein\nAttachments\nMAJOR INITIATIVES REPORT: HEALTH BLOCK GRANT\n1. Then and Now Facts\nOn February 25, 1976, the President proposed to improve the efficiency\nand equity of health services to the poor by consolidating sixteen\nfederal health programs, including Medicaid, into one $10 billion\nblock grant to the States. Every State would receive more in fiscal\nyears 1977, 1978 and 1979 than was received in fiscal year 1976.\nNo State would ever receive less than it did in fiscal year 1976.\n2. Highlights and Key Numbers\nThe President submitted to Congress the Financial Assistance for\nHealth Care Act. Its objectives are to:\no\nimprove access to quality health care at reasonable\ncosts;\nachieve, over time, a more equitable distribution\nof federal health dollars among States in relation-\nship to those persons most in need;\nincrease State and local control over health spending\nto:\na. allow each State to set its own priorities\nfor health programs based on the particular\nneeds of its low-income population and its\nresources;\nb. allow each State to integrate its programs\ninto a cohesive total; and\nC. increase the States' motivation to control\nrising health care costs;\nrestrain the growth of federal spending and the federal\nbureaucracy and reduce red tape.\nPage 2\nThe proposal includes a requirement for a State-developed \"State\nHealth Care Plan.\" Public participation in the development of\nthe plan is required to ensure that increased State responsibility\nis coupled with expanded public involvement in the formation of\nState health policies.\n3. Problems Encountered in the Last Two Years\nNo congressional committee hearings have been held, or likely are\nto be held, on the bill.\nHEW and OMB staff have consulted extensively with representatives\nof State and local governments. Major issues raised are:\nFunding levels under the block grant are insufficient.\nBoth initial grants and subsequent inflation increments\nare not adequate to maintain existing program levels or\nkeep pace with escalating health costs.\nThe allocation formula results in too drastic a\nredistribution of federal dollars.\nWill the Federal Government or Congress overlay elaborate\nregulatory requirements on States in the future? States\nare concerned that subsequent regulations and standards\nimplementing the consolidation would be exceedingly\ncostly and require large increases in State health\nexpenditures.\nThe required State Health Care Plan and the planning process\nshould be the responsibility of State government. Under\nP.L. 93-641, the National Health Planning Act, States were\ngiven regulatory responsibility, but no control over plan-\nning for the allocation of State, local and private health\nresources. The law gave planning to private, non-profit\nagencies that reported to the Secretary of HEW.\nCompliance, audit and enforcement procedures should be\nthe responsibility of each State.\n4. Key Quotes\nFrom the President's message to Congress, February 25, 1976:\nPage 3\n\"In the past 10 year period (1965-1975) Federal spending for\nhealth has increased from $5 billion to $37 billion. With\ngreater Federal funding has come a multitude of Federal\nprograms, regulations and restrictions -- all motivated by\nthe best of intentions but each adding to the confusion\nand overlap and inequity that now characterizes our efforts\nat the national level.\n\"The Financial Assistance for Health Care proposal is being\nsubmitted after extensive consultation with organizations\nrepresenting the publicly elected officials who will be\nresponsible for administering the program. I believe this\nproposal represents a major step toward overcoming some of\nthe most serious defects in our present system of Federal\nfinancing of health care.\n\"My proposal is designed to achieve a more equitable\ndistribution of Federal health dollars among States and\nto increase State control over health spending. My\nproposal also recognizes the appropriate Federal role\nin providing financial assistance to State and local\ngovernments to improve the quality and distribution of\nhealth services.\n\"The enactment of this legislation will achieve a more\nequitable distribution of Federal health dollars by\nproviding funds according to a formula giving primary\nweight to a State's low-income population. The formula\nalso takes into account the relative tax effort made by\na State and the per capita income of that State.\"\n5. Contact with Outside Groups\nNational Governors' Conference\nNational Association of County Officials\nNational Conference of Mayors\nNational League of Cities\nNational Conference of State Legislatures\nHEALTH\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nOFFICE OF THE SECRETARY\nU.S.A.\nWASHINGTON, D.C. 20201\nJuly 20, 1976\nTo:\nMichael Licata\nExecutive Secretary\nFrom:\nDirector\nOffice for Civil Rights\nSubject: Major Initiatives Report for Domestic Council on\nSection 504 of the Rehabilitation Act of 1973\nI. Background and Status\nOn September 26, 1973, the Rehabilitation Act of\n1973 became law. Section 504 of the Act broke new\nlegislative ground in that it was the first major\ncivil rights enactment to protect the rights of the\ntwenty-five million handicapped persons in the\nUnited States. This section provides that no quali-\nfied handicapped person shall be denied the benefits\nof or be discriminated against in any federally\nassisted program or activity. (See Tab A.) In 1974,\nthe definition of handicapped person in the Act was\namended SO that the protections of section 504\napply to any person who has a physical or mental\nimpairment which substantially limits one or more\nof that person's major life activities, any person\nwho has a record of such an impairment, and any\nperson who is regarded as having such an impair-\nment. Section 504, however, applies only to quali-\nfied handicapped persons. Thus, the Act would\nallow an employer to refuse to hire a blind bus\ndriver but would not allow the automatic dis-\nqualification of a blind teaching applicant because\nof blindness.\nOn April 28, 1976, President Ford issued Execu-\ntive Order 11914, which provides for a govermentwide\nenforcement scheme under which the Secretary of Health,\nEducation, and Welfare is assigned responsibility to\ncoordinate the federal government's implementation of\nsection 504. (See Tab B.) The Secretary is to develop\nstandards for determining who are handicapped persons\nand guidelines for determining what are discriminatory\npractices. The executive order also delineates specific\nenforcement procedures and sanctions for noncompliance,\nincluding termination of federal financial assistance.\nPage 2\nMr. Licata\nResponsibility for development and implementation of a\nsection 504 compliance program for HEW was delegated to\nthe Office for Civil Rights. On May 17, 1976, the Depart-\nment published in the Federal Register a Notice of Intent\nto Issue Proposed Rules under section 504. (See Tab C.)\nThis notice raised a number of fundamental issues con-\ncerning section 504 and sought public comment on these\nissues before the Department published a notice of pro-\nposed rulemaking. The Department received over 400\ncomments as a result of this notice and, after analyzing\nthem, published in the Federal Register on July 16, 1976,\na Notice of Proposed Rulemaking allowing at least 60 days\nfor public comment. (See Tab D.)\nII. Highlights and Problems\nWhile section 504 raises a myriad of issues, several\nare so basic and critical that they should be highlighted:\nthe definition of handicapped person, the elimination of\narchitectural barriers and the provision of services to\nbeneficiaries of federal programs. The phrase \"regarded\nas having such an impairment\" in the statutory definition\nis open-ended and presents a problem of interpretation.\nThis part of the definition recognizes that a person who\nis not otherwise significantly handicapped may be dis-\ndriminated against on the basis of being perceived as\nhandicapped. In this category are included persons who are\ngrossly disfigured, dwarfs and persons who limp.\nArchitectural barriers exclude handicapped persons from\nprograms and employment opportunities by preventing access\nto and use of the facilities where such programs are offered.\nWhile the intent of section 504 is to prohibit the existence\nof such barriers, the statute does not address this issue\nseparately and the expense involved in eliminating\narchitectural barriers in existing facilities is consider-\nable. The Department's approach to this situation re-\nquires that recipients of federal funds devise and implement\na plan which will, within three years, ensure that its\nfederally assisted program, when viewed in its entirety,\nbe accessible. This provision would not require that\nevery building or part of every building be made free of\narchitectural obstacles but encourages flexibility and\ncreativity in making sure that no beneficiary is denied\naccess to federal programs because of handicap.\nThe thrust of section 504 in the provision of edu-\ncation, health and social services is to ensure that handi-\ncapped persons receive an equal opportunity to participate\nin federally assisted services. Thus, providers of ser-\nvices must ensure that notice and information is given to\nPage 3\nMr. Licata\ntheir beneficiaries in such a manner that it can be under-\nstood by handicapped persons with impaired sensory or\nspeaking skills. In the area of elementary and secondary\neducation, the proposed regulation is consistent with\nnumerous recent court decisions and Public Law 94-142, the\nEducation for All Handicapped Children Act of 1975. It\nrequires that a recipient provide as suitable, adequate\nand free an education to each handicapped person of school\nage, regardless of the nature or severity of the person's\nhandicap, as it provides to nonhandicapped persons; that\nthe education be provided in the most normal setting feasible;\nthat, before placement of a student in a specialized instruc-\ntion setting, the student be properly evaluated and given\ncertain due process rights; that no handicapped child be\nexcluded from the educational process on the basis of\nhandicap; and that nonacademic and extra-curricular\nservices and activities be provided in a nondiscriminatory\nmanner.\nSeveral factors contributed to the Department's delay\nin promulgating proposed rules for section 504. The lack of\nCongressional guidance on the enactment of the statute has\nbeen a persistent problem in formulating proposed rules.\nSimilarly, the amendments to the definition of handicapped\nperson contributed to the difficulty of drafting a regula-\ntion for section 504 and added to the delay. Finally, the\nneed to develop an inflationary impact statement, which esti-\nmated the regulator's economic costs and benefits, added\nsubstantially to the amount of time which it took the\nDepartment to prepare proposed rules.\nIII. Contact with Outside Groups\nThe Department has involved non-HEW people in a mean-\ningful manner at all stages of development of the proposed\nrules. Before the publication of the May 17 Notice of\nIntent, the Office for Civil Rights met with over sixty\nnational organizations, constituent groups and agencies of\nfederal and state governments. The Office has conducted\nseminars with recipients of federal funds, service organi-\nzations and consumer groups and has participated in a\nnumber of national conferences. In addition to receiving\nthe comments from the May 17 notice, the Office for Civil\nRights held ten seminars across the country to solicit\npublic comment on the issues raised in the May 17 notice.\nOCR is presently planning to hold town meetings in twenty-two\ncities across the United States in August and September\nto generate public interest in and knowledge of section\n504 and the Department's responsibility in enforcing section 504.\nThat 9eng\nMartin H. Gerry\nLIBRARY\nPage 4\nMr. Licata\nTab A: Section 504, Rehabilitation Act of 1973\nTab B: Executive Order 11914\nTab C: May 17, 1976 Notice of Intent to Publish Proposed Rules\nTab D: July 16, 1976, Notice of Proposed Rulemaking\nPublic Law 93-112\n93rd Congress, H. R. 8070\nSeptember 26, 1973\nREHABILITATION ACT OF 1973\nNONDISCRIMINATION UNDER FEDERAL GRANTS\nSEC. 504. No otherwise qualified handicapped individual in the\nUnited States, as defined in section 7(6), shall, solely by reason of his\nhandicap, be excluded from the participation in. be denied the benefits\nof, or be subjected to discrimination under any program or activity\nreceiving Federal financial assistance.\nSec. 7. For the purposes of this Act:\n(6) The term \"handicapped individual\" means any individual who\n(A) has a physical or mental disability which for such individual\nconstitutes or results in a substantial handicap to employment and (B)\ncan reasonably be expected to benefit in terms of employability from\nvocational rehabilitation services provided pursuant to titles I and III\nof this Act.\nPublic Law 93-516\n93rd Congress, H. R. 17503\nDecember 7, 1974\nREHABILITATION ACT AMENDMENTS OF 1974\nSec. 111. (a) Section 7(6) of such Act is amended by adding at the\nend thereof the following new sentence: \"For the purposes of titles\nIV and V of this Act, such term means any person who (A) has a\nphysical or mental impairment which substantially limits one or more\nof such person's major life activities, (B) has a record of such an\nimpairment, or (C) is regarded as having such an impairment.\".\nNondiscrimination With Respect\nto the Handicapped in Federally\nAssisted Programs\nExecutive Order 11914. April 28, 1976\nBy virtue of the authority vested in me by the Constitu-\n(c) No such suspension or termination of, or refusal\ntion and statutes of the United States of America, includ-\nto award or continue, Federal financial assistance shall\ning section 301 of title 3 of the United States Code, and\nbecome effective unless there has been an express finding,\nas President of the United States, and in order to provide\nafter opportunity for a hearing, of a failure by the recipi-\nfor consistent implementation within the Federal Govern-\nent of, or applicant for, Federal financial assistance to\nment of section 504 of the Rehabilitation Act of 1973 (29\ncomply with the requirements adopted pursuant to this\nU.S.C. 794), it is hereby ordered as follows:\norder; however, such suspension or termination of, or\nSECTION 1. The Secretary of Health, Education, and\nrefusal to award or continue, Federal financial assistance\nWelfare shall coordinate the implementation of section\nshall be limited in its effect to the particular program or\n504 of the Rehabilitation Act of 1973, as amended, here-\nactivity or part thereof with respect to which there has\ninafter referred to as section 504, by all Federal de-\nbeen such a finding of noncompliance.\npartments and agencies empowered to extend Federal\nSEC. 4. Each Federal department and agency shall\nfinancial assistance to any program or activity. The Secre-\nfurnish the Secretary of Health, Education, and Welfare\ntary shall establish standards for determining who are\nsuch reports and information as the Secretary requests\nhandicapped individuals and guidelines for determining\nand shall cooperate with the Secretary in the implementa-\nwhat are discriminatory practices, within the meaning of\ntion of section 504.\nsection 504. The Secretary shall assist Federal departments\nSEC. 5. The Secretary of Health, Education, and Wel-\nand agencies to coordinate their programs and activities\nfare may adopt rules and regulations and issue orders\nand shall consult with such departments and agencies, as\nwhich he deems are necessary to carry out his respon-\nnecessary, so that consistent policies, practices, and pro-\nsibilities under this order. The Secretary shall ensure that\ncedures are adopted with respect to the enforcement of\nsuch rules, regulations, and orders are not inconsistent\nsection 504.\nwith, or duplicative of, other Federal Government policies\nSEC. 2. In order to implement the provisions of section\nrelating to the handicapped, including those policies\n504, each Federal department and agency empowered to\nadopted in accordance with sections 501, 502, and 503 of\nprovide Federal financial assistance shall issue rules, regu-\nthe Rehabilitation Act of 1973, as amended, or the Archi-\nlations, and directives, consistent with the standards and\ntectural Barriers Act of 1968 (42 U.S.C. 4151 et seq.).\nprocedures established by the Secretary of Health, Educa-\nGERALD R. FORD\ntion, and Welfare.\nThe White House,\nSEC. 3. (a) Whenever the appropriate department or\nApril 28, 1976.\nagency determines, upon all the information available to\n[Filed with the Office of the Federal Register, 11:07 a.m.,\nit, that any recipient of, or applicant for, Federal financial\nApril 28, 1976]\nassistance is in noncompliance with the requirements\nadopted pursuant to this order, steps to secure voluntary\ncompliance shall be carried out in accordance with stand-\nards and procedures established pursuant to this order.\n(b) If voluntary compliance cannot be secured by\ninformal means, compliance with section 504 may be\neffected by the suspension or termination of, or refusal to\naward or continue, Federal financial assistance or by other\nappropriate means authorized by law, in accordance with\nstandards and procedures established pursuant to this\norder.\nMEMORANDUM\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nOFFICE OF THE SECRETARY\nTO\n: Mr. Michael J. Licata\nDATE: July 20, 1976\nExecutive Secretary to the Department\nTHROUGH: The Under Secretary\nbe\nFROM : Director, Office of Investigations\nSUBJECT: Major Initiatives Report\nRe Your Memo of July 20\n1. Secretary Mathews announced the formation of an\nindependent Office of Investigations reporting directly\nto the Under Secretary effective November 30, 1975.\nThis unit was to investigate all allegations of criminal\nfraud and related matters. The new office has no\nresponsibility for physical security, personnel security\nclearances, or for personnel investigations except as\nthey related to fraud or conflict of interest. On\nDecember 28, 1975, the Investigations Branch of the\nOffice of Administrative Appraisal and Planning, Social\nSecurity Administration, was transferred to the Office\nof Investigations.\n2. Congressional approval to increase the staff of the new\nOffice of Investigations to 74 was obtained. A career\nappointment of an experienced, professional investigator\nto the position of Director, Office of Investigations\nwas made April 19, 1976.\nIn a series of announcements, the Secretary and Under\nSecretary affirmed their complete support and backing\nfor this office and their intention to see that it was\noperated in an independent, professional, and non-partison\nmanner. The new Director was directed to open and close\ninvestigations on his own authority and to present cases\ndirectly to the Department of Justice for prosecution.\nSince April 1976, efforts have been under way to select\nexperienced and competent personnel to fill the authorized\ncomplement. Personnel are now on board in all ten of the\nHEW Regional Offices. Twenty-five professional investigators\nare in the field and at headquarters. Offers are pending\nto three more investigators and selections are now being\nprocessed to fill vacant slots. Cases are being investigated,\npresented to the Justice Department, and prosecutions are\ngoing forward.\nMr. Michael J. Licata -- page 2\nOther moves were made to emphasize the Department's\ninterest in the elimination of fraud and abuse. A\nclose rapport was established between the HEW Audit\nAgency and the Office of Investigations and steps were\ntaken to increase the independence of the Audit Agency.\nA special Fraud and Abuse Unit for Medicaid was\nestablished within the Social and Rehabilitation Service\nto seek out program areas where potential fraud and\nprogram abuse might exist. Teams from this unit have\ninitiated pilot projects in Massachusetts and Ohio to\nformulate and improve techniques to detect potential\nfraud and abuse.\nJohn J. I Walsh\nTHE WHITE HOUSE\nWASHINGTON\nJuly 27, 1976\nMEMORANDUM FOR THE HONORABLE DAVID MATHEWS\nSECRETARY OF HEALTH, EDUCATION AND WELFARE\nFROM:\nJIM CANNON\nAt the Midwestern Governors Conference yesterday, Governor\nRhodes spoke to me about these two matters.\nWould you ask someone on your staff to arrange to have an\nappropriate response sent directly to Governor Rhodes?\nThank you.\nGERALE & FORD LIBRARY\nTHE OHIO STATE UNIVERSITY\nJuly 19, 1976\nThe Honorable James A. Rhodes\nGovernor, State of Ohio\nColumbus, Ohio 43215\nDear Governor Rhodes:\nThis is in response to your request for information relating to significant\nFederal--State actions pending regarding The Ohio State University Comprehen-\nsive Cancer Center.\n1. A Construction Grant for $3,000,000 in Federal funds to con-\nstruct a $4,000,000 Cancer Research Center is being resubmitted\nto the National Cancer Institute on 1 October 1976, $1,000,000\nof State matching funds are included in the University's 1977-83\nCapital Plan submitted to the Board of Regents on July 6, 1976.\nThis reapplication has been discussed with Drs. Rauscher and Fox\nof the National Cancer Institute.\n2. On June 28, 1976 The Ohio State University submitted to the\nNational Cancer Institute a Grant Application for $1,806,138\nfor the three year April 1, 1977 to March 31, 1980 time period\nto fund a Developmental Cancer Control Program, for the Ohio\nValley Region. (See Attachment 1). This application is under\nconsideration by the National Cancer Institute.\n3. On January 28, 1975 The Ohio State University submitted to\nthe National Cancer Institute a Grant Application for $1,055,369\nto fund a three year (September 1, 1975 to August 31, 1978)\ngrant entitled \"Carcinogenic Mechanisms: In Vitro Studies\"\n(See Attachment 2). This grant application was recommended for\napproval by the National Cancer Institute staff in the reduced\namount of $596,169 (See Attachment 3). This grant is still\npending and funding is dependent upon the availability of funds\nand project priority.\nYour support and interest in the OSU Medical Center, our Comprehensive\nCancer Center and the enhancement of our ability to provide better medical\nLIBRARY\nTHE\nGOVERNOR\nSTATE OF OHIO\nOFFICE OF THE GOVERNOR\nOHIO\nCOLUMBUS 43215\nOF\nJAMES A. RHODES\nGOVERNOR\nJuly 20, 1976\nThe Honorable David F. Mathews\nSecretary of Health, Education, and Welfare\nGERALD FORD LIBEARY\nWashington, D. C.\n20201\nDear Secretary Mathews:\nOhio faces a severe financial crisis in its Medicaid program,\nThe severity of this crisis is apparent when you compare the\nappropriation of $471 million (state funds plus projected federal\nearnings) which is available for fiscal year 1977 with the pro-\njected expenditures of $597 million required to support the\nFY 77 Medicaid program in its present form.\nThis situation is further compounded by the fact that Ohio is\nunder court order not to reduce the scope of the current program\nuntil pre-reduction hearings are provided to eligible recipients.\nThe projected deficit of $126 million in the Medicaid program has\nbeen the subject of much publicity, legislative committees have\nexamined the program and many medical provider associations have\nprovided suggestions and recommendations. Since the projected\ndeficit includes both state funds and federal earnings, Ohio needs\nyour recommendations as to how this situation might best be re-\nsolved. I understand that the federal funds required to support\nthe program are indeed available to Ohio but only if the state\ncertifies that it can provide the necessary state matching funds.\nYour verification of this requirement would be most helpful.\nWithout an increase in state matching funds, Ohio cannot continue\nthe existing Medicaid program, The problem becomes critical on\nNovember 15, 1976, when the federal estimates for the January-\nMarch 1977 quarter are due. Without an increase in state funds\nprior to this date, Ohio will not be able to certify the avail-\nability of sufficient state funds to maintain the Medicaid program\nfor FY 77. It is anticipated that the current appropriation will\nbe exhausted in February 1977 and Ohio will be forced to discontinue\nthe Medicaid program for lack of funds.\nI plan to propose a reallocation of state funds that will insure\nthe continuation of Ohio's Medicaid program through fiscal year\n1977. Immediate action is necessary if Ohio is to avoid a repeat\nof the FY 76 crisis when Medicaid funds were exhausted on May 11,\n1976. I need your support to reinforce the necessity for a speedy\nbut effective solution to the Medicaid crisis, Attached is a\nsuggested letter for your signature which would accomplish that\npurpose.\nHealth\nTHE WHITE HOUSE\nWASHINGTON\n7/27/76\nTO:\nSPENCE JOHNSON\nFROM: JIM CANNON\nWhat is the status on this?\nFORD LIBRARY & GERALD\nstatus\nHEALTH.\nCC Johnson\nPATIENT\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nOFFICE OF THE SECRETARY\nUSA\nWASHINGTON, D.C. 20201\nJUL 16 1976\nMEMORANDUM FOR THE HONORABLE JAMES M. CANNON\nI am writing in response to your memorandum of June 24 in\nwhich you request further information concerning my memorandum\nof June 18 to the President. As you know, the National\nInstitutes of Health (NIH) released guidelines on June 23\nfor recombinant deoxyribonucleic acid (DNA) research supported\nor conducted by NIH. The purpose of the committee I proposed\nto the President in my memorandum would be to review and\ncoordinate Federal agency policies and actions in this re-\nsearch area in light of the NIH guidelines.\nIn response to your questions concerning the proposed committee,\nit is my intent that this committee shall be composed solely\nof Federal officers and employees representing all departments\nand agencies which conduct, support, or have possible regulatory\nauthority over the conduct of recombinant DNA research. Such\na committee is specifically excluded from the provisions of the\nFederal Advisory Committee Act. The relevant section of that\nAct is as follows:\nSec. 3. For the purpose of this Act-\n(2) The term \"advisory committee\" means any\ncommittee, board, commission, council,\nconference, panel, task force, or other similar\nFORD i GERALD LIBRARY\ngroup, or any subcommittee or other subgroup\nthereof (hereafter in this paragraph referred to\nas \"committee\"), which is--\n(A) established by statute or reorganization\nplan, or\n(B) established or utilized by the President,\nor\n(C) established or utilized by one or more\nagencies,\nin the interest of obtaining advice or recommendations\nfor the President or one or more agencies or officers\nof the Federal Government, except that such term\nexcludes (i) the Advisory Commission on Intergovernmental\nRelations, (ii) the Commission on Government Procurement,\nand (iii) any committee which is composed wholly of\nfull-time officers or employees of the Federal Government.\n(Emphasis added.)\nThe Honorable James M. Cannon\n2\nThus, the proposed committee, inasmuch as it would be composed\nsolely of Federal officers and employees, would not need to be\nchartered under this Act.\nYou also ask how this proposed committee relates to S. 2515,\nwhich would modify the present National Commission for the\nProtection of Human Subjects of Biomedical and Behavioral\nResearch. In the bill, which recently passed the Senate, there\nis a provision concerning recombinant DNA research. The\nCommission is authorized to conduct a study of the ethical,\nsocial, legal, and safety implications of recombinant DNA\nresearch and devise guidelines, if appropriate. I am enclosing\na copy of a letter that I am planning to send to Congressman\nHarley O. Staggers, Chairman of the Committee on Interstate\nand Foreign Commerce of the House of Representatives, commenting\non the bill. In the letter is outlined the Department's\nstated opposition to S. 2515, including comments that the study\nof recombinant DNA research proposed for the Commission would\nduplicate the efforts of NIH.\nIn my view, it is most important that we be able to proceed\nas expeditiously as possible to organize an intergovernmental\ncommittee to review the experience of NIH and, where appropriate,\nmake recommendations for the other Federal departments and\nagencies and possibly for the private sector. Legislative\nprospects for S. 2515 are uncertain at best. Further, even if\nthe Congress were to pass legislation to create such a\nPresidential Commission, over the Administration's objections,\nand it were to become law, there would be certain administrative\ndelays in reorganizing and reconstituting such an entity. And\neven if the Commission were to undertake such a study, it would\nstill not meet the stated needs of the committee that I am\nproposing. The committee would have a far broader mandate\nand a broader representation of interested parties.\nI have received a considerable amount of correspondence on\nthis research activity in the past several months. In these\nletters there has been special emphasis by public commentators\non the need for uniformity in the conduct of recombinant DNA\nresearch. The committee I propose would be most responsive\nto this public concern. I strongly urge you to recommend to\nthe President that I be allowed to proceed in this matter\nwithout undue delay.\nThrojone Lynch\nActing\nSecretary\nEnclosure\nTHE\nATION\nDEPARTMENT OF HEALTH, EDUCATION. AND WELFARE\nUSA\nDRAFT\nThe Honorable Harley 0. Staggers\nChairman, Committee on Interstate\nFORD\nand Foreign Commerce\nHouse of Representatives\nWashington, D.C. 20515\nDear Mr. Chairman:\nThis is in response to your request for a report on S. 2515, a bill \"To\namend the Public Health Service Act to establish the President's Commis-\nsion for the protection of human subjects involved in biomedical and\nbehavioral research, and for other purposes.\"\nIn summary, we oppose S. 2515 as passed by the Senate because the existing\nstatutorily established National Commission for the Protection of Human\nSubjects of Biomedical and Behavioral Research has yet to complete its\nrecommendations. These are to include the development of an effective\nFederal administrative mechanism for applying its ethical guidelines to\nresearch programs conducted or supported by Government departments or\nagencies, including its definition of the function and authority of the\nproposed National Advisory Council for the Protection of Subjects of\nBiomedical and Behavioral Research.\nWe feel that the recommendations of the present National Commission will\nmake an invaluable contribution toward the development of a consistent\nGovernment-wide plan for the protection of human subjects of biomedical\nand behavioral research. Assuming that such an administrative framework\nwill be based on the guidelines currently being recommended to the\nDepartment of Health, Education, and Welfare, we favor an Executive\nOrder to extend Departmental regulations on the protection of human\nsubjects uniformly to all other Federal agencies and departments rather\nthan legislative creation of a new Presidential Commission.\nS. 2515, as amended, would in effect replace the Commission created in\nTitle II of the National Research Act. The new President's Commission\nwould be permanent and would contain eleven members plus ex officio\nadvisors from the Department of Health, Education, and Welfare, the\nDepartment of Defense, the Central Intelligence Agency, the Science\nAdvisor to the President, and the Veterans Administration. The President's\nCommission would assume the functions, powers, and duties of the current\nNational Commission and expand its jurisdiction to encompass all Federal\ndepartments and agencies conducting research involving human subjects.\nPage 2 - The Honorable Harley 0. Staggers\nIn addition to the duties prescribed for the National Commission, the\nPresident's Commission would be responsible for continually reviewing\nand analyzing the ethical, social, and legal implications of all research\non human subjects supported by the Federal Government, and for making\nappropriate recommendations concerning the protection of human subjects\nto the supporting agency. These recommendations would be published in\nthe Federal Register and, if the responsible agency chooses not to\nfollow them, the negative determination and the reasons for it would be\npublished in the Federal Register.\nThe President's Commission would also be required to study the ethical,\nsocial, legal, and safety implications of recombinant DNA research on\nresearch personnel, human subjects of the research, and the public at\nlarge.\nWe strongly endorse efforts to protect human subjects of biomedical and\nbehavioral research. However, in addition to establishing a mechanism\nwhich we do not believe is necessary, the structure of the proposed\ncommission contains some administrative shortcomings.\nFirst, the President's Commission would be independently advisory to the\nseveral Federal agencies and departments, rather than to the Government\nas a whole. Thus, there would be an opportunity not only for uncoordi-\nnated advice but for disparate, inconsistent, and possibly conflicting\nresponses on the part of agencies conducting similar research. Second,\nthe proposed ex officio membership would not represent the extent of\nbiomedical research carried out by other Federal agencies, such as the\nEnergy Research and Development Administration, National Aeronautics and\nSpace Administration, Department of Transportation, or Department of\nAgriculture. Third, there are no positions or funds authorized to\nsupport the activities of the proposed Commission.\nOne of the recommendations already made by the National Commission for\nthe Protection of Human Subjects is that there be established a national\nreview body to consider ethical problems raised by research proposals\nwhenever the application of recommended standards proves difficult. The\nDepartment of Health, Education, and Welfare is establishing an Ethical\nAdvisory Board to provide advice to the Public Health Service and other\ncomponents of the Department on ethical issues and on classes of applica-\ntions or proposals which (1) must be submitted to the Board or (2) need\nnot be submitted to the Board (45 CFR 46.204). Creation of the Ethical\nAdvisory Board will create a more flexible instrument for dealing with\nethical dilemmas concerning human research subjects than the proposed\nPresidential Commission.\nPage 3 - The Honorable Harley O. Staggers\nFinally, we are very aware of the controversy over recombinant DNA\nresearch and have recently released guidelines according to which support\nmay be given for research conducted by grantees, contractors, and intra-\nmural scientists. The National Institutes of Health, Public Health\nService, has gone to great lengths to involve the Congress, the public,\nand the press in the decisionmaking process which has addressed the\nsocial, legal, ethical, and safety implications of such research. It\nhas sought and received advice from many sectors--scientists, ethicists,\nlawyers, and consumer representatives--and has taken all comments into\naccount in preparing the guidelines for this activity. While we do not\noppose having the guidelines reviewed by another advisory body, we feel\nthis is already being done under present authority.\nWe therefore recommend that S. 2515 not be favorably considered at this\ntime, and that any legislative initiatives concerning Federal regulation\nof research involving human subjects be delayed until the existing\nNational Commission for the Protection of Human Subjects has made its\nfinal report and recommendations to the President and the Congress as\nrequired by the National Research Act.\nWe are advised by the Office of Management and Budget that there is no\nobjection to the presentation of this report from the standpoint of the\nAdministration's program.\nSincerely,\nSecretary\nexecutive Health\nTHE WHITE HOUSE\nIV/1976/ST43/PAILAS\nWASHINGTON\nJuly 30, 1976\nMEMORANDUM FOR:\nJIM CANNON\nFROM:\nSPENCE JOHNSON Sy\nSUBJECT:\nInvitation to the President to address\nAmerican Hospital Association convention\nto be held September 20 - 23.\nThis would be an excellent opportunity for the President\nto make a major health policy statement in the Fall. This\nwill be the largest health conference with nationwide\nrepresentation between Labor Day and the election. I\nwould strongly recommend that if the President is going\nto make a major health address, this forum be used.\nFORD :- LIBRARY 07V8.35\nTHE WHITE HOUSE\nWASHINGTON\nK-\nclose\nout!\nG.\nRECEIVED\nAUG 21976\nCENTRAL FILES\nTHE WHITE HOUSE\nWASHINGTON\nJuly 22, 1976\nMEMORANDUM FOR:\nJIM CANNON\nFROM:\nWILLIAM NICHOLSON\nWN\nSUBJECT:\nInvitation to the President to address\nAmerican Hospital Association convention\nto be held September 20-23 in Dallas\nI would appreciate your comments and recommendation on the attached\ninvitation to the President.\nThank you.\nCOMMENTS:\nEXECUT\nIr/1976/5T43/Dallad\nJuly 22, 1976\nMEMORANDUM FOR:\nJIM CANNON\nFROM:\nWILLIAM NICHOLSON\nSUBJECT:\nInvitation to the President to address\nAmerican Hospital Association convention\nto be held September 20-23 in Dallas\nI would appreciate your comments and recommendation on the attached\ninvitation to the President.\nThank you.\nCOMMENTS:\nFORD 2 LIBRARY 938870\nRECEIVED\nJUL 23 1976\nCENTRAL FILES\n\\\nEXECUTIVE\nJuly 19, 1976\nDear Mr. McMahon:\nOn behalf of the President, I wish to acknowl-\nedge and to thank you for the letter you addressed\nto him on June 30 in which you invited him to\nappear before the American Hospital Association\nconvention in Dallas on Monday September 20 or\non Thursday, September 23.\nWe are carrying this invitation forward for\nconsideration as the President's calendar for\nthis time frame is under advisement and we will\nbe back in touch with you as soon as it is\npossible to give you a more definite answer.\nIn the meantime, please be assured of the\nPresident's appreciation for your thoughtful-\nness and his warm, good wishes.\nSincerely,\nWilliam W. Nicholson\nDirector\nScheduling Office\nY\nMr. J. Alexander McMahon\nPresident\nX\nAmerican Hospital Association\n840 North Lake Shore Drive\nChicago, Illinois 60611\ncc/w incmg to M. Widner for Sept. 20 folux follow_ up\nCC: two opies to nancy Gemmell\nand\njeh\n9\nRECEIVED\nJUL201976\nCENTRAL FILES\nHOSPITAL\nAMERICAN\nMM\nASSOCIATION\nAmerican Hospital Association\nFOUNDED\n-2581\nJ. ALEXANDER McMAHON\nPresident\nJune 30, 1976\nMy dear Mr. President\nA recent Gallup Poll indicated that the American public\nconsiders the issue of health care one of the highest\npriorities that the federal government can address.\nTherefore, it is appropriate and it is with pleasure\nthat the $40 billion hospital industry offers you a\nforum before our Association convention in Dallas,\nSeptember 20-23, 1976.\nThe American Hospital Association represents most of\nthe nation's 7,000 hospitals who are providing inpatient\nand outpatient care for approximately 150 million people\nthis year.\nOther U.S. Presidents, including your predecessor, have\nused this industry's rostrum to discuss health and\nrelated issues. More than 14,000 delegates, who repre-\nsent three million hospital employees, are expected at\nDallas for this annual conference which will be heavily\ncovered by the national media, as well as the health\ncare press. These delegates, and the hospital industry,\nwould be most anxious to hear how you perceive the issue\nof health care in the next four years.\nWe would be pleased to have you speak either to our\nplenary session on Monday, September 20, or the plenary\nsession on Thursday, September 23. These sessions will\nbe of equal length, and we are also offering Mr. Carter\nthe same opportunity to speak at one of these sessions.\n840 North Lake Shore Drive\nChicago, Illinois 60611\n312 645-9400\nPresident Ford/2\n6/30/76\nSo that the necessary arrangements can be made, may I\nhear from you as soon as possible.\nSincerely yours\nJ. Alexander McMahon\ncc: Mrs. Mary Louise Smith\nChairman\nNational Republican Party\nPresident Gerald R. Ford\nThe White House\nWashington, DC 20500\nTHE WHITE HOUSE\nWASHINGTON\nJuly 30, 1976\nMEMORANDUM FOR:\nJIM CANNON\nFROM:\nSPENCE JOHNSO\nInvitation to of the President to address\nSUBJECT:\nAmerican Hospital Association convention\nto be held September 20 - 23.\nThis would be an excellent opportunity for the President\nto make a major health policy statement in the Fall. This\nwill beathe largest health conference with nationwide\nrepresentation between Labor Day and the election. I\nwould strongly recommend that if the President is going\nto make a major health address, this forum be used.\n976 AUG 2\nFORD is LIBRARY GERALD\nMAssengale\nJuly 22, 1976\nMEMORANDUM FOR:\nJIM CANNON\nFROM:\nWILLIAM NICHOLSON\nSUBJECT:\nInvitation to the President to address\nAmerican Hospital Association convention\nto be held September 20-23 in Dallas\n1 would appreciate your comments and recommendation on the attached\ninvitation to the President.\nThank you.\nCOMMENTS:\nBERALD FORD LIBRAPT\nCC: Art Quern\nStaffed out by comp.\nTHE WHITE HOUSE\nH.E.W.\nWASHINGTON\nAugust 5, 1976\nADMINISTRATIVELY CONFIDENTIAL\nFORD i LIBRARY GERALD\nMEMORANDUM FOR:\nJIM CANNON\nFROM:\nJIM CONNORS JEE.\nThe attached articles were returned in the President's outbox with\nthe following notation:\n\"Good P.R.\"\nPlease follow-up with appropriate action.\nCC: Dick Cheney\nThe Atlanta Tournal\nCovers Dixie Like the Dew\nSince 1883\nJames M. Cox, Chairman 1939-1957 - James M. Cox Jr., Chairman 1957-1974\nJeck Torver, Publisher\nJack Spalding, Editor\n14-A *****\nJULY 26, 1976\nWorth Trying\nPAGE 12\nTHE INDIANAPOLIS STAR\nWhere the Spirit of the Lord is, there is Liberty\nII Corinthians 3:17\nEUGENE C. PULLIAM-1889-1975\nPublisher 1944-1975\nEUGENE S. PULLIAM, Publisher\n\"Let the people know the, facts and the\ncountry will be saved. \"-Abraham Lincoln\nAsking The People\nTHE DALLAS TIMES HERALD\nEDITORIALS\n2-C**** Tuesday, July 27, 1976,\nRegulations reform\n, illiens\nPage A4-Austin, Texas\nTuesday, July 27, 1976\nJim Fain, Publisher; Ray Mariotti, Editor; Bill Meroney,\nGeneral Manager; Bob Easter, Circulation Director; Tim\nBrown, Systems Director; Everett Bushell, Advertising\nDirector; George W. Spaulding, Classified Manager.\nPublic agency\nTULSAM WORLD\n\"Oklahoma's Greatest Newspaper\"\nEUGENE LORTON\n1869-1949\nPage 8-A\nMonday, July 26, 1976\nBYRON V. BOONE, Publisher\nROBERT E. LORTON, President\nSID STEEN, Executive Editor\nWALTER BISCUP, Editor of Editorial Page\nPHIL DESSAUER, Associate Editor\nALEX ADWAN, Associate Editor\nTRAVIS WALSH, Managing Editor\nBIBLE THOUGHT\nAlways and for everything giving thanks.-Eph. 5:20.\nWelfare Goes Public\nTHE DAILY OKLAHOMAN\nE. K. GAYLORD (1873-1974)\nPublished Every Morning by The Oklahoma Publishing Co., 500 N. Broadway\nPost Office Box 25125. Oklahoma City 73125\nTelephone (405) 232-3311\nEdward L. Gaylord, President and Publisher\nHoward Nicks\nVice-President and General Manager\nCharles L. Bennett\nExecutive Editor\nGates Oliver\nAdvertising Director\nHelge Holm\nCirculation Director\nEdith Gaylord Harper\nSecretary\nAll unsolicited items are sent to The Daily Oklahoman at the owner's risk and the\ncompany accepts no responsibility for their return. The Associated Press is exclu-\nsively entitled to the use of all news credited to it or not otherwise credited in this\npaper and also the local news we publish. Entire contents copyrighted. Reproduc-\ntion without permission is prohibited.\n10\nWednesday, July 28, 1976\nSlower to Regulate\nS. Fowler\nThe l'uscaloosa News\nTommy -7-\n45-7263\nEDITORIALS and COMMENTS\nStevenson\nThis page contains opinions and comments. Editorials in the lefthand column express The News'\nNews Staff Writer\nviewpoints. Other Items which appear are expressions of those whose name appears and may. or may not,\nreflect The News opinions. Comments on subjects of general public interest from readers are accepted\nAll letters must be signed, home address given, and conform to published standards limiting length to 300\nwords, be in good taste and reason THE EDITORS.\nMonday, July 26, 1976 3\nHEW to seek public's\nIt appears the U.S. Department of\nHealth, Education and Welfare has\nended up with egg on its bureaucratic\nadvice\nface once too often and HEW Secretary\n-5- -\nSan Francisco OF WEST Chronicle\nFounded 1865 by Charles and M. H. de Young\nGeorge T. Comeron, Publisher 1925-55\nCharles de Young Thieriot\nEditor and Publisher\nGordon Pates\nRichard Thieriot\nManaging Editor\nAssociate Editor\nTempleton Peck\nEditorial Page Editor\nEditorials\nPublic Input\nTo HEW Rules\n-3-\n22-A MORNING ADVOCATE, Baton Rouge, La., Wed., July 28, 1976\n:\nEditorial\nTaking Bureaucracy\nOut of the Vacuum\nHerbert S. Fowler\nThe Tuscaloosa News\n245-7263\n-6-\nEDITORIALS and COMMENTS\nThis page contains opinions and comments. Editorials in the lefthand column express The News'\nviewpoints. Other Items which appear are expressions of those whose name appears and may, or may not,\nreflect The News' opinions. Comments on subjects of general public interest from readers are accepted.\nAll letters must be signed, home address given, and conform to published standards limiting length to 300\nEditorials\nwords. be in good taste and reason THE EDITORS\nJuly 25, 1976\nReforms\nHEW Secretary Mathews is to be commended\nfor his revamp efforts\nEDITORIALS\nAssociate Editor\nHEW Reform of Regulations\nThe Miami Herald\nJAMES L. KNIGHT, Chaitman\nLEEVILLS, Publisher ALVAH H. CHAPMAN, H., President DON SHOEMAKER, Editor BEVERLY R. CARTER, Gen. Mgr.\nIs Good News for the Public\nLAWS passed by Congress may not\nfies a contrite Secy. Mathews, \"when\nGEORGE BEEBE, Associate Publisher LÀRRY JINKS, Executive Editor JOHN D. PENNEKAMP,\nmean anything, as Bill Klem would say,\nthe need for a regulation arose, the De-\nuntil they are interpreted in the Federal\npartment consulted largely with groups\nRegister or other nosy places by the\nhaving a special interest in a given pro-\nfederal regulatory\ngram and then. proposed a regulation\nRON MARTIN, Managing Editor\nSunday, July 25, 1976\nsencies.\nwhich often reflected their common\nAs the immortal\npreconceptions. The public at large was\nbaseball umpire ex-\nshut out of the process.\" For an agency\nplained, \"Some of\nwhich was created 23 years ago (and is\nem is strikes, and\nold enough to vote: this, pray, is an\nsome of 'em is\nelection year) the confession is sensa-\nballs, but they ain't\ntional.\nnothing until I calls\nJOHN S. KNIGHT, Editor Emeritus\nBut we think Secy. Mathews ought\nem.\"\nto be taken at his word. The whole\nWell, sir, the\nsubject of government regulation, as\nworm is turning at\nPresident Ford has emphasized often,\nleast several de-\nneeds the swift broom of reform.\ngrees. Health, Edu-\nMathews\ncation and Welfare\nSome businesses which otherwise are\nBRO\nSecretary David Mathews announces\nquick to bernoan the stern eye of gov-\nthat HEW today is instituting \"sweep-\nernment, actually like regulation and\ning reforms in the way the Department\nare aghast when it is criticized as a\ndevelops and issues its regulations.\nform of governmental oppression of\n2-E\n\"Most extreme of these,\" he goes on,\nfree enterprise competition.\nis the requirement for HEW to consult\nIn the main, however, most regula-\nceoments of the public before it\ntion is counterproductive It increases\nDaily Record\nOur Opinion\nMorristown, N.J.\nJuly 27, 1976\nHEW Reforms\nno you believe in the HE'W That is\nA Good Idea\nMany critics, by no means all of\nservice announcemer\nthem political conservatives, have\nreleases, professional a\ncomplained of growing im-\norganizations, maili\nperiousness on the part of some of-\nFederal Register, and t\nficials within the huge\nment's 10 regional off\nbureaucracy of the federal Depart-\nregional office for Vir\nment of Health, Education and\nPhiladelphia.) Some\nVelfare (HEW). A recent decree\nmethods of communica\nJanning father-son, mother-\nsimilar to what the fede\ndaughter outings at public\nment already is doing,\nchools-a decree promptly\nlike the use of public n\nSuspended by an angry President\nhear the opinions prior 1\nFord-was editorially lambasted\ntion of regulations, do a\nas \"civil rights madness\" by the\ninnovative.\nIberal Washington Post, for ex-\nOther changes call\nemple.\nMathews are training s\nLast week, Rep. G. William\nHEW officials in how\n/hitehurst, R-Va., scored a re-\nregulations in clear\nCional HEW official for \"bureau-\nEnglish (now there'\ncratic arrogance\" because\nrevolutionary proposal\nof his alleged refusal to an-\nreview of regulations to\nwer questions of a Norfolk news-\nare doing what was ínt\nRichmond Times-Dispatch\nALAN $. DONNAHOE, President and Associate Publisher\npaper reporter aboût how funds\nmodification of regula\nDAVID TENNANT BRYAN, Chairman and Publisher\nJOHN E LEARD, Executive Editor ALF GOODYKOONTZ, Managing Editor\nEDWARD GRIMSLEY, Editor of the Editorial Page\nwere spent for certain social\nimpose too many or to\nprograms. (HEW has a $128 billion\nrequirements on pro\nudget this year.) Whitehurst said\nministrators.\nhas demanded a full accounting\nSecretary Mathews s\nMonday, July 25, 1976\nexpenditures for the programs\ngiven credit for a good\nquestion.\nExamples of the problem could\nall up this page and then some. But\nlast comes an indication that the\nroblem is recognized at\nHEW-by the top man, at least, if\nnot necessarily by all his un-\nderlings.\nHEW Secretary David Mathews\nannounced yesterday a package\nof \"reforms\" that is meant to give\nthe general public more of a say in\nNEW regulation-writing. The\nregulatory process is HEW's most\nintrusive channel into people's\nAves, said Mathews, declaring:\nPerts\n*For far too long HEW has gone to\nMathews\nWash. Post\nJuly 27, 1976, EDIT.\n!\nHEW and Rulemania\nThe Washington Star\nJOE L ALLERITTON, Publisher\nJAMES G. BELLOWS Editor\nSIDNEY EPSTEIN, Managing Editor EDWIN M. YODER JR., Associate Editor\nFRIDAY, JULY 23, 1976\nHEW: Regulating the regulators\nRile\nHEW\nTHE WHITE HOUSE\nWASHINGTON\nAugust 12, 1976\nMEMORANDUM FOR:\nFROM:\nJIM CANNON\nI am writing in response to your memoranda of July 16\nSECRETARY Jan DAVID MATHEWS\nand June 18 in which you propose to create an interagency\ncommittee to review and coordinate Federal agency policies\nand actions in DNA research supported or conducted by NIH\nin light of the recent NIH guidelines.\nSince you would have the authority to establish the committee\nwithout the President's approval, according to the General\nCounsel of HEW, we have no objection and feel the decision\nis best made by you.\nIf you decide to create such a committee and feel that a\nletter from the President to the heads of departments and\nagencies urging their cooperation would be useful, please\nsend me a draft letter.\nFORD is LIBRARY GERALD\nFOR IMMEDIATE RELEASE\nAugust 6, 1976\nOffice of the White House Press Secretary\nTHE WHITE HOUSE\nSTATEMENT BY THE PRESIDENT\nI have been following with great concern the investigations\ninto the cause of the tragic outbreak of illness in Pennsylvania\nthis past week. All Americans join me, I am sure, in their\nsympathy for the families of the more than 20 people who have\ndied and their hope for the speedy recovery of those people\ncurrently under treatment.\nI am greatly relieved that these tragic deaths were not\nthe result of swine flu. But let us remember one thing:\nthey could have been. The threat of swine flu outbreak this\nyear is still very genuine. Data from the scientific\ncommunity still clearly supports the need for a full-scale\ninoculation program. Clinical tests conducted to date\nclearly demonstrate that the vaccine is both safe and\neffective. There is no excuse to let the legislative program\nthat I proposed seven weeks ago a program that could safeguard\nthe lives of many, many Americans - be delayed any longer.\nHealth, Education, and Welfare Secretary Mathews and the\nleaders of Congress reported to me on Wednesday that after\nlong hours of hearings, discussions, and negotiations, Congress\nfinally would act yesterday to pass legislation to provide\nswine flu vaccine to all the American people. Needless to\nsay, I was keenly disappointed to learn last evening that the\nnews from the doctors in Pennsylvania has led to another\nslowdown in the Congress.\nI am frankly dumb founded that Congress, which took\nthe time and effort to enact 111-advised legislation to\nexempt its own Members from State income taxes, has failed\nto act to protect 215 million Americans from the threat\nof swine flu. Drug manufacturers have produced over 100\nmillion doses of swine flu vaccine in bulk form, but the\nvaccine has not been prepared in suitable dosage form,\npending action by the Congress.\nBecause of these legislative delays, we are, at this\nmoment, at least six weeks away from beginning an effective\ninoculation program. Had Congress acted promotly after I\nsubmitted my proposal we would have been in a position to\ndispatch shipments of vaccine today.\nAs President, I cannot accept any further dilly-dallying\nby the Congress on this legislation that could be vital to\nthe health and safety of our people.\nI call on the Congress to act quickly before its\nnext recess - so that the health of the American people\nwill be fully protected.\n##\nGERALD FORD LIBRARY\nRile - abortions\nTHE WHITE HOUSE\nHealth\nWASHINGTON\nAugust 27, 1976\nMEMORANDUM FOR:\nDICK CHENEY\nTHRU:\nJACK MARSH\nFROM:\nMAX FRIEDERSDORF\nM.\nPress inquiries have been received from Nick Thimmesch\nand John Lofton regarding the administration's position\non the amendment to the Labor/HEW appropriations bill\nbanning the use of federal funds for abortions.\nAs you know, the Hyde amendment passed the House and is\nin disagreement with the Senate version.\nThe inquiries from Lofton to me came in the form of a letter\nwhich I have merely acknowledge.\nThimmesch's questions came after I retured his fifth phone\ncall this afternoon with the concurrence of Jack Marsh\nwho anticipated what the question might be.\nThimmesch said that Carter has taken a position in support\nof the Hyde amendment which, of course, if inconsistent with\nother Carter statements and the Democratic platform.\nAt the time of the floor consideration of the Hyde amendment\nHyde requested our position and I ran the amendment through\nthe system here at the White House but we never took a\nformal position.\nI recommend this issue be analyzed by Jim Cavanaugh and Mike\nDuval because I am sure we can anticipate further press\ninquiries because of the strong focus on the Congressional\nlegislation.\nCC:\nRon Nessen\nJim Cavanaugh\nMike Duval\nJim Cannon\nGERALD FORD LIBRARY\nFile\nTHE WHITE HOUSE\nWASHINGTON 8/27/76\nJack -\nwho is\nhandling\ndomestic policy\nfitues now?\nFORD & GERALD LIBRARY\nDonester comicil?\nor others ?\nJui"
}